Phase I/II Study of Avelumab in Pediatric Cancer Participants

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 1

Conditions: Refractory or Relapsed Solid Tumors; Lymphoma

Treatments: Drug: Avelumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03451825

MS100070-0306

2017-002985-28 (EudraCT Number)

Details and patient eligibility

About

This is a multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid tumors (including central nervous system tumors) and lymphoma for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

The study was planned to be conducted in 2 parts: the dose-finding part (Phase I) and the tumor-specified expansion part (Phase II). However, Phase II was cancelled due to limited clinical benefit of PD-L1 monotherapy in pediatric participants.

Enrollment: 21 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects 0 to less than 18 years of age at the time of first treatment dose with histologically or cytologically confirmed solid malignant tumors (including CNS tumors) or lymphoma for which no standard therapy is available
• Confirmed progression on or refractory to standard therapy or no standard therapy available.
• Availability of archival formalin-fixed, paraffin-embedded block containing tumor tissue, or slides, or a fresh/recent tumor biopsy prior to avelumab treatment for subjects in Phase 2
• Adequate bone marrow, kidney, and liver function
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
• Concurrent anticancer treatment or immunosuppressive agents
• Prior organ transplantation
• Significant acute or chronic infections
• Other significant diseases or conditions that might impair the subject's tolerance of trial treatment
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Avelumab: 10 miligram per kilogram (mg/kg)

Experimental group

Treatment:

Drug: Avelumab

Drug: Avelumab

Avelumab 20mg/kg

Experimental group

Treatment:

Drug: Avelumab

Drug: Avelumab